Head to Head Study Epi proColon and FIT

Launched by EPIGENOMICS, INC · Apr 17, 2012

Keywords

ClinConnect Summary

There is strong evidence supporting the use of FOBT in CRC screening, with the earliest randomized controlled trials demonstrating a reduction in CRC incidence and mortality from CRC screening. Despite the implementation and incremental improvements in gFOBT- and FIT-based tests, they continue to represent a small percentage of CRC screening and currently remain largely the province of large, integrated healthcare delivery systems. Reasons for the limited adoption of stool-based testing are complicated, but include lack of physician recommendation, patient preferences, and cultural barriers...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Group A
• • Willing and able to sign an informed consent and adhere to study requirements
• • 50 - 84 years of age at blood and stool sampling
• • Colonoscopic diagnosis of colorectal carcinoma
• • Colonoscopy within 6 months before inclusion into study
• • Blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery
• • Group B
• • Willing and able to sign an informed consent and adhere to study requirements
• • 50 - 84 years of age at blood and stool sampling
• • Able to provide blood and stool sample prior to bowel prep and colonoscopy
• Exclusion Criteria:
• • Group A
• • Subject with curative biopsy during colonoscopy
• • Group A and B
• • Previous personal history of CRC or previous colonocopy resulting in a recommendation to repeat colonoscopy at an interval less than 10 years
• • Neoadjuvant treatment
• • Familial risk for colorectal cancer
• • History of inflammatory bowel disease
• • Acute or chronic gastritis
• • Current diagnosis of any other cancer
• • Overt rectal bleeding or bleeding hemorrhoids
• • Known infection with HIV, HBV, or HCV
• • Subject concurrently receiving intravenous fluid at the time of the sample collection